Clinical Trials

Inclusion Criteria: 

• Demographic characteristics (e.g. gender, age) and the health state, presence or absence of a medical condition/disease.
• Required laboratory results, diagnostic methods, criteria for classification of current status, as measured within XX days prior to randomization. List specific tests and documentation methods.  
• Prior therapy, if any.  Consider listing specific prior treatments.  Consider listing the allowable duration of prior therapy for the specific population to be studied (e.g., treatment-naïve, treatment-experienced or prior-treatment-failed “salvage” participants). 
• Ability to understand study procedures and to comply with them for the entire length of the study.
• If men and women of reproductive capability will be enrolled, indicate whether contraception is necessary and required. If yes, include details of allowable contraception methods for trial.

Exclusion Criteria: 

• Specify health status or any clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
•  Clinical/laboratory indicators of current status, obtained within XX days prior to   randomization.  List the specific tests to be performed and the narrowest acceptable range of laboratory values for exclusion, consistent with disease and/or safety. Include as many as necessary. 
• Specify any exclusion related to pregnancy, lactation, or plans to become pregnant. Specify methods for assessing current status and willingness to use contraception, if applicable. Include as many as necessary.
• Use of [excluded drugs, behavioral interventions, devices, etc.] within XX days prior to study entry. Treatment with another investigational drug or intervention (with time frame).
• For drug studies: allergy/sensitivity to study drugs or their ingredients.
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
• Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/27/2025. Questions regarding updates should be directed to the study team contact.